Model Number 72077-01 |
Device Problems
Unable to Obtain Readings (1516); Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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This complaint was received via user report and has been reported to fda.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.The reported product is not expected to be returned as reporter indicated the device was discarded.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.This report covers 2 of 8 events.
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Event Description
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Abbott diabetes care (adc) received a medwatch report which reported the following information: an incompatibility of the freestyle libre 3 application with current mobile device operating system update and unable to obtain glucose values as a result."the operating system on my cellphone is version 17 and has been since it was released by apple in september 2023.The call center rep told me that the sensors are not compatible with os version 17." an adc customer service was able to contact the customer but the customer did not provided any additional information.Based on the information provided, there was no report of serious injury associated with this event.
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Event Description
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Abbott diabetes care (adc) received a medwatch report which reported the following information: an incompatibility of the freestyle libre 3 application with current mobile device operating system update and unable to obtain glucose values as a result."the operating system on my cellphone is version 17 and has been since it was released by apple in september 2023.The call center rep told me that the sensors are not compatible with os version 17." an adc customer service was able to contact the customer but the customer did not provided any additional information.Based on the information provided, there was no report of serious injury associated with this event.
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Manufacturer Narrative
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The reported complaint was investigated and determined that there were no issues with the user's reported application that would have led to the complaint.The user reported issues with receiving glucose values as a result of incompatible os.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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